Biocare Medical Recalls Mislabeled Mach 4 Mouse Probe Vials
Biocare Medical is recalling a single lot of Mach 4 Mouse Probe vials that may be mislabeled as HRP-Polymer.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a labeling error that could affect diagnostic accuracy, fitting the criteria for a moderate severity score.
Plain-English summary
Biocare Medical, LLC is recalling a single lot (082715) of its Mach 4 HRP Polymer kit. The recall involves 93 units of the Mach 4 Mouse Probe vial, which may have been mislabeled as HRP-Polymer. The product is an immunohistochemistry reagent intended for in vitro use in detecting specific antibodies on formalin-fixed, paraffin-embedded tissues.
The recall was initiated because some vials within the identified lot may have incorrect labeling. The affected lot has an expiry date of 01/2017. The product was distributed nationwide in the United States to the states of Kansas, California, Arizona, Oregon, Florida, Colorado, Massachusetts, Kentucky, New York, Illinois, Missouri, North Carolina, Texas, Pennsylvania, Oklahoma, South Carolina, Tennessee, and Georgia, as well as to Hungary, Canada, and Bolivia.
Users of the product should stop using the affected vials and contact Biocare Medical for further instructions. The mislabeling could lead to the use of the wrong reagent in immunohistochemistry procedures, potentially affecting the accuracy of diagnostic results.
The recalled product
- Product
- Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and…
- Manufacturer
- Biocare Medical, LLC
- Hazard
- Affected units
- 93
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot number 082715
- Expiry 01/2017.
Distribution
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